Computed tomography enhanced fluoroscopic system, device, and method of utilizing the same

ABSTRACT

A system and method for enhanced navigation for use during a surgical procedure including planning a navigation path to a target using a first data set of computed tomography images previously acquired; navigating a marker placement device to the target using the navigation path; placing a plurality of markers in tissue proximate the target; acquiring a second data set of computed tomography images including the plurality of markers; planning a second navigation path to a second target using the second data set of computed tomography images; navigating a medical instrument to a second target; capturing fluoroscopic data of tissue proximate the target; and registering the fluoroscopic data to the second data set of computed tomography images based on marker position and orientation within the real-time fluoroscopic data and the second data set of computed tomography images.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. application Ser. No.15/972,156, filed on May 6, 2018, which is a continuation of U.S.application Ser. No. 14/880,338, now U.S. Pat. No. 9,974,525, filed onOct. 12, 2015, which claims the benefit of and priority to U.S.Provisional Application Nos. 62/073,287 and 62/073,306, filed on Oct.31, 2014. This application is related to U.S. patent application Ser.No. 14/880,361, now U.S. Pat. No. 9,986,983, filed on Oct. 12, 2015. Theentire contents of each of the above applications are herebyincorporated herein by reference.

BACKGROUND Technical Field

The present disclosure relates to a system, apparatus, and method ofnavigation and position confirmation for surgical procedures. Moreparticularly, the present disclosure relates to a system and method forenhanced navigation of an extended working channel or catheter and oneor more medical instruments positionable therethrough in one or morebranched luminal networks of a patient and confirming placement of thosemedical instruments prior to initiating treatment or biopsy.

Description of Related Art

Microwave ablation is a commonly applied method for treating variousmaladies affecting organs including the liver, brain, heart, lung andkidney. Commonly, one or more imaging modalities, whether magneticresonance imaging, ultrasound imaging, computer tomography (CT), as wellas others will be employed by a clinician to identify areas of interestwithin the patent and ultimately targets for treatment. Once identified,an area of interest will typically require a biopsy using a biopsy toolto confirm whether treatment and/or observation are necessitated at aparticular time. This biopsy is typically performed under one of anumber of image guidance modalities, and/or in conjunction with anavigation system. If the biopsy reveals that the area of interest ismalignant, it may prove useful to treat the area using microwaveablation.

Microwave ablation may be performed by transmitting microwave energythrough a needle inserted percutaneously in the patient to ablate thearea of interest. Alternatively, where practicable, an endoscopicapproach can be undertaken, where, once navigated to the identifiedtarget, a flexible microwave ablation catheter can be placed in thetarget to ablate the area of interest. The endoscopic approach isparticularly useful when treating luminal networks of the body such asthe lungs.

To enable the endoscopic approach, for example in the lungs,endobronchial navigation systems have been developed that use CT imagedata to create a navigation plan to facilitate advancing a navigationcatheter (or other suitable device) through a bronchoscope and a branchof the bronchus of a patient to the area of interest. Endobronchialnavigation may be employed both in the diagnostic (i.e., biopsy) phaseand the treatment phases. Electromagnetic tracking may be utilized inconjunction with the CT data to facilitate guiding the navigationcatheter through the branch of the bronchus to the area of interest. Incertain instances, the navigation catheter may be positioned within oneof the airways of the branched luminal networks adjacent to or withinthe area of interest to provide access for one or more medicalinstruments.

Once the navigation catheter is in position, fluoroscopy may be used tovisualize medical instruments including biopsy tools, such as, forexample, brushes, needles and forceps, as well as treatment tools suchas an ablation catheter, as they are passed through the navigationcatheter and into the lung and to the area of interest. Conventionalfluoroscopy is widely used during medical procedures as a visualizationimaging tool for guiding medical instruments inside the human body.Although medical instruments like catheters, biopsy tools, etc., areclearly visible on a fluoroscopic picture, organic features such as softtissue, blood vessels, suspicious tumor lesions etc., are eithersomewhat or completely transparent and thus hard to identify withconventional fluoroscopy.

During procedures, such as a biopsy or ablation, a fluoroscopic imagemay be used by a clinician to aid in visualizing the placement of amedical instrument within a patient's body. However, although themedical instrument is visible in the fluoroscopic image, the area ofinterest or target tissue is generally somewhat transparent and notnecessarily clearly visible within the image. Moreover, fluoroscopicimages render flat 2D images on which it can be somewhat challenging toassess three-dimensional position of the medical instrument. As such,the clinician is not provided all the information that could be desiredto visualize the placement of the medical device within the patient'sbody relative to the area of interest.

SUMMARY

As can be appreciated, a microwave ablation catheter that ispositionable through one or more branched luminal networks of a patientto treat tissue may prove useful in the surgical arena.

Aspects of the present disclosure are described in detail with referenceto the figures wherein like reference numerals identify similar oridentical elements. As used herein, the term “distal” refers to theportion that is being described which is further from a user, while theterm “proximal” refers to the portion that is being described which iscloser to a user.

According to one aspect of the present disclosure, a method of enhancednavigation is provided including planning a navigation path to a targetusing a first data set of computed tomography images previouslyacquired, navigating a marker placement device to the target using thenavigation path, placing a plurality of markers in tissue proximate thetarget, acquiring a second data set of computed tomography imagesincluding the plurality of markers, planning a second navigation path toa second target using the second data set of computed tomography images,navigating a medical instrument to the second target; capturingfluoroscopic data of tissue proximate the markers, and registering thefluoroscopic data to the second data set of computed tomography imagesbased on marker position and/or orientation within the fluoroscopic dataand the marker position and/or orientation within the second data set ofcomputed tomography images.

A sample of the target tissue, such as tissue proximate the target, maybe retrieved for biopsy or other purposes. Additionally, the method mayfurther include displaying a representation of the second data set ofcomputed tomography images and the fluoroscopic data on a graphical userinterface. The first target and the second target may identifysubstantially the same area of interest. Further, at least a portion ofthe second data set of computed tomography images may be combined withthe fluoroscopic data to generate a combined image for display on thegraphical user interface. The combined image may be generated viasuperimposing, fusing, or overlaying the second data set of computedtomography images with the fluoroscopic data. The fluoroscopic data maybe a fluoroscopic image, fluoroscopic images, or fluoroscopic video.

Additionally, the method may further include navigating a microwaveablation device to the target and activating the microwave ablationdevice to ablate tissue proximate the target. Additionally, the methodmay further include analyzing the fluoroscopic data and determiningwhether a medical instrument is correctly positioned relative to thetarget, and adjusting a position of the medical instrument relative tothe target. A second fluoroscopic data set of the tissue proximate thetarget may also be acquired from a second perspective relative to apatient such that a three-dimensional position of the medical instrumentis viewable from a different angle relative to the patient. The secondfluoroscopic data set may also be analyzed to determine whether thethree-dimensional position of the medical instrument relative to thetarget is correct, and if not, the three-dimensional position of themedical instrument relative to the target may be adjusted.

In yet another aspect of the present disclosure a non-transitorycomputer readable storage medium is provided including instructions thatwhen executed by a computing device, cause the computing device to plana navigation path to a target using a first data set of computedtomography images previously acquired, navigate a marker placementdevice to the target using the navigation path, acquire a second dataset of computed tomography images including a plurality of markerspreviously placed in tissue proximate the target, plan a secondnavigation path to a second target using the second data set of computedtomography images, navigate a medical instrument to the second targetusing the second navigation path, capture fluoroscopic data of tissueproximate the plurality of markers using a fluoroscope, and register thefluoroscopic data to the second data set of computed tomography imagesbased on marker position and/or orientation within the fluoroscopic dataand marker position and/or orientation within the second data set ofcomputed tomography images.

The first target and the second target may identify substantially thesame area of interest. A sample of the target, such as tissue proximatethe target, may be retrieved for biopsy or other purposes. Additionally,the computing device may further display a representation of the seconddata set of computed tomography images and the fluoroscopic data on agraphical user interface. Further, at least a portion of the second dataset of computed tomography images may be combined with the fluoroscopicdata to generate a combined image for display on the graphical userinterface. The combined image may be generated via superimposing,fusing, or overlaying the second data set of computed tomography imageswith the fluoroscopic data. The fluoroscopic data may be a fluoroscopicimage, fluoroscopic images, or fluoroscopic video.

Additionally, the computing device may further enable navigation of amicrowave ablation device to the target and activation of the microwaveablation device to ablate tissue proximate the target. Additionally, thecomputing device may further analyze the fluoroscopic data and determinewhether device medical instrument is correctly positioned relative tothe target. A second fluoroscopic data set of the first or second targetmay also be acquired from a second perspective relative to the patientsuch that a three-dimensional position of the medical instrument isviewable from a different angle. The second fluoroscopic data set mayalso be analyzed to determine whether the three-dimensional position ofthe medical instrument relative to the target tissue is correct, and ifnot, the three-dimensional position of the medical instrument relativeto the target may be adjusted.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and embodiments of the present disclosure are describedhereinbelow with references to the drawings, wherein:

FIG. 1 depicts a portion of a user interface with navigational data froma navigation plan overlaid on a live fluoroscopic image;

FIG. 2 is a perspective view of one illustrative embodiment of anelectromagnetic navigation (EMN) system in accordance with the presentdisclosure;

FIG. 3 is an end view of a fluoroscopic imaging C-arm incorporated inthe EMN system of FIG. 2 ;

FIG. 4 is a flow chart of a method for performing a procedure withenhanced navigation using the system of FIG. 3 in accordance with theinstant disclosure;

FIG. 5 is a flow chart of a method for performing enhanced navigationusing the system of FIG. 3 in accordance with the instant disclosure;

FIG. 6 is an illustration of an example fluoroscopic image/videocaptured by a C-arm showing markers and an extended working channel of acatheter assembly positioned within a target region of a patient inaccordance with the instant disclosure; and

FIG. 7 is a flow chart of a method for adjusting the position of amedical instrument relative to a target in accordance with the instantdisclosure.

DETAILED DESCRIPTION

The present disclosure is generally directed to addressing thenavigational and location confirmatory shortcomings of the previouslyknown navigation and fluoroscopic imaging confirmation methods anddevices. According to one embodiment of the present disclosure,following navigation of a catheter to an area of interest, afluoroscopic image (or series of fluoroscopic images) is captured. Byregistering the location of markers previously placed within the patientand captured in the fluoroscopic image to the location of markers whichappear in 3D model data generated from a previously acquired CT imagedata set, the fluoroscopic image can be overlaid with data from the 3Dmodel data including target location data, navigation pathway data,luminal network data and more.

Detailed embodiments of the present disclosure are disclosed herein.However, the disclosed embodiments are merely examples of thedisclosure, which may be embodied in various forms and aspects.Therefore, specific structural and functional details disclosed hereinare not to be interpreted as limiting, but merely as a basis for theclaims and as a representative basis for teaching one skilled in the artto variously employ the present disclosure in virtually anyappropriately detailed structure.

FIG. 1 depicts the image outcome of one embodiment of the presentdisclosure. In FIG. 1 , a composite fluoroscopic image 10 is displayed.The composite fluoroscopic image 10 may be presented on a display as anadditional view of an Electromagnetic Navigation (EMN) system 100 (FIG.2 ) used for navigation. Alternatively, the image may be presented on afluoroscopic image viewer separate from the EMN system 100. The field ofview of the fluoroscopic image 10 includes a distal portion of anextended working channel (EWC) 12 that has been maneuvered pursuant to apathway plan, as will be described in greater detail below. Thefluoroscopic image 10 is also overlaid with a variety of data originallydeveloped and derived from navigation software. This additional dataoverlaid on the fluoroscopic image 10 includes a target 14, a pathwayplan 16, luminal pathways of the area being imaged 18, and markers 20.With this enhanced fluoroscopic image 10 a clinician is allowed tovisualize in real time the final placement of the EWC 12 in relation tothe pathway plan 16, the target 14 and the markers 20 to ensure accuratefinal placement, as well as discern if there is any unintended movementof the EWC 12 as a result of tool exchanges into and out of the EWC 12.

FIG. 2 depicts an aspect of an EMN system 100 configured for reviewingCT image data to identify one or more targets 14, planning a pathway toan identified target 14 (planning phase), navigating an EWC 12 to thetarget 14 (navigation phase) via a user interface, and confirmingplacement of the EWC 12 relative to the target 14. One such EMN systemis the ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY® system currently sold byCovidien LP. The target 14 is a computer generated representation,created during the planning phase, of the tissue of interest identifiedby review of the CT image data. As described above, followingnavigation, a medical instrument such as a biopsy tool may be insertedinto the EWC 12 to obtain a tissue sample from the tissue located at, orproximate to, the target 14.

As shown in FIG. 2 , EWC 12 is part of a catheter guide assembly 40. Inpractice, the EWC 12 is inserted into bronchoscope 30 for access to aluminal network of the patient “P.” Specifically, EWC 12 of catheterguide assembly 40 may be inserted into a working channel of bronchoscope30 for navigation through a patient's luminal network. A locatable guide(LG) 32, including a sensor 44 is inserted into the EWC 12 and lockedinto position such that the sensor 44 extends a desired distance beyondthe distal tip of the EWC 12. The position and orientation (6 DOF) ofthe sensor 44 relative to the reference coordinate system, and thus thedistal end of the EWC 12, within an electromagnetic field can bederived. Catheter guide assemblies 40 are currently marketed and sold byCovidien LP under the brand names SUPERDIMENSION® Procedure Kits, orEDGE™ Procedure Kits, and are contemplated as useable with the presentdisclosure. For a more detailed description of the catheter guideassemblies 40, reference is made to commonly-owned U.S. patentapplication Ser. No. 13/836,203 filed on Mar. 15, 2013 by Ladtkow et al,and U.S. Pat. No. 7,233,820 the entire contents of both are herebyincorporated by reference.

EMN system 100 generally includes an operating table 20 configured tosupport a patient “P” a bronchoscope 30 configured for insertion throughthe patient's “P's” mouth into the patient's “P's” airways; monitoringequipment 120 coupled to bronchoscope 30 (e.g., a video display, fordisplaying the video images received from the video imaging system ofbronchoscope 30); a tracking system 50 including a tracking module 52, aplurality of reference sensors 54, and a transmitter mat 56; a computingdevice 125 including software and/or hardware used to facilitateidentification of a target 14, pathway planning to the target 14,navigation of a medical instrument to the target 14, and confirmation ofplacement of an EWC 12, or a suitable device therethrough, relative tothe target 14.

FIG. 3 depicts another view of the EMN system 100, including afluoroscopic imaging device 110 capable of acquiring fluoroscopic orx-ray images or video of the patient “P.” The images, series of images,or video captured may be stored within the imaging device 110 ortransmitted to computing device 125 for storage, processing, anddisplay. Additionally, the imaging device 110 may rotate about thepatient “P” so that images may be acquired from different angles orperspectives relative to the patient “P.” Imaging device 110 may includea single imaging device or more than one imaging device. In embodimentsincluding multiple imaging devices, each imaging device may be adifferent type of imaging device or the same type. Further detailsregarding the imaging device 110 are described in U.S. Pat. No.8,565,858, which is incorporated by reference in its entirety herein.

Computing device 125 may be any suitable computing device including aprocessor and storage medium, wherein the processor is capable ofexecuting instructions stored on the storage medium. The computingdevice 125 may further include a database configured to store patientdata, CT data sets including CT images, fluoroscopic data sets includingfluoroscopic images and video, navigation plans, and any other suchdata. Although not explicitly illustrated, the computing device 125 mayinclude inputs, or may otherwise be configured to receive, CT data setsand other data described herein. Additionally, computing device 125includes a display configured to display graphical user interfaces suchas those described below. Computing device 125 may be connected to oneor more networks through which one or more databases may be accessed.

With respect to the planning phase, computing device 125 utilizescomputed tomographic (CT) image data for generating and viewing athree-dimensional model of the patient's “P's” airways, enables theidentification of a target 14 on the three-dimensional model(automatically, semi-automatically, or manually), and allows fordetermining a pathway through the patient's “P's” airways to tissuelocated at the target 14. More specifically, the CT scans are processedand assembled into a three-dimensional CT volume, which is then utilizedto generate a three-dimensional model of the patient's “P's” airways.The three-dimensional model may be displayed on a display associatedwith computing device 125, or in any other suitable fashion. Usingcomputing device 125, various views of the three-dimensional model ortwo-dimensional images generated from the three-dimensional model arepresented. The three-dimensional model may be manipulated to facilitateidentification of target 14 on the three-dimensional model ortwo-dimensional images, and selection of a suitable pathway through thepatient's “P's” airways to access tissue located at the target 14 can bemade. Once selected, the pathway plan, 3D model, and images derivedtherefrom can be saved and exported to a navigation system for useduring the navigation phase(s). One such planning software is theILOGIC® planning suite currently sold by Covidien LP.

With respect to the navigation phase, a six degrees-of-freedomelectromagnetic tracking system 50, e.g., similar to those disclosed inU.S. Pat. Nos. 8,467,589, 6,188,355, and published PCT Application Nos.WO 00/10456 and WO 01/67035, the entire contents of each of which isincorporated herein by reference, or other suitable positioningmeasuring system, is utilized for performing registration of the imagesand the pathway and navigation, although other configurations are alsocontemplated. Tracking system 50 includes a tracking module 52, aplurality of reference sensors 54, and a transmitter mat 56. Trackingsystem 50 is configured for use with a locatable guide 32 andparticularly sensor 44. As described above, locatable guide 32 andsensor 44 are configured for insertion through an EWC 12 into apatient's “P's” airways (either with or without bronchoscope 30) and areselectively lockable relative to one another via a locking mechanism.

As shown in FIGS. 2 and 3 , transmitter mat 56 is positioned beneathpatient “P.” Transmitter mat 56 generates an electromagnetic fieldaround at least a portion of the patient “P” within which the positionof a plurality of reference sensors 54 and the sensor element 44 can bedetermined with use of a tracking module 52. One or more of referencesensors 54 are attached to the chest of the patient “P.” The six degreesof freedom coordinates of reference sensors 54 are sent to computingdevice 125 (which includes the appropriate software) where they are usedto calculate a patient coordinate frame of reference. Registration, asdetailed below, is generally performed to coordinate locations of thethree-dimensional model and two-dimensional images from the planningphase with the patient's “P's” airways as observed through thebronchoscope 30, and allow for the navigation phase to be undertakenwith precise knowledge of the location of the sensor 44, even inportions of the airway where the bronchoscope 30 cannot reach. Furtherdetails of such a registration technique and their implementation inluminal navigation can be found in U.S. Patent Application Pub. No.2011/0085720, the entire contents of which, is incorporated herein byreference, although other suitable techniques are also contemplated.

Registration of the patient “P's” location on the transmitter mat 56 isperformed by moving LG 32 through the airways of the patient “P.” Morespecifically, data pertaining to locations of sensor element 44, whilelocatable guide 32 is moving through the airways, is recorded usingtransmitter mat 56, reference sensors 54, and tracking module 52. Ashape resulting from this location data is compared to an interiorgeometry of passages of the three-dimensional model generated in theplanning phase, and a location correlation between the shape and thethree-dimensional model based on the comparison is determined, e.g.,utilizing the software on computing device 125. In addition, thesoftware identifies non-tissue space (e.g., air filled cavities) in thethree-dimensional model. The software aligns, or registers, an imagerepresenting a location of sensor 44 with a the three-dimensional modeland two-dimensional images generated from the three-dimension model,which are based on the recorded location data and an assumption thatlocatable guide 32 remains located in non-tissue space in the patient's“P's” airways. Alternatively, a manual registration technique may beemployed by navigating the bronchoscope 30 with the sensor 44 topre-specified locations in the lungs of the patient “P”, and manuallycorrelating the images from the bronchoscope to the model data of the 3Dmodel.

Following registration of the patient “P” to the image data and pathwayplan, a user interface is displayed in the navigation software whichsets forth the pathway that the clinician is to follow to reach thetarget 14. One such navigation software is the ILOGIC® navigation suitecurrently sold by Covidien LP.

Once EWC 12 has been successfully navigated proximate the target 14 asdepicted on the user interface, the locatable guide 32 may be unlockedfrom EWC 12 and removed, leaving EWC 12 in place as a guide channel forguiding medical instruments including without limitation, opticalsystems, ultrasound probes, biopsy tools, ablation tools (i.e.,microwave ablation devices), laser probes, cryogenic probes, sensorprobes, and aspirating needles to the target 14.

Having described the components of system 100, depicted in FIGS. 2 and 3the following description of FIGS. 4-7 provides an exemplary workflow ofusing the components of system 100 in conjunction with CT imaging toachieve the result depicted in FIG. 1 . FIGS. 4-7 , enable a method ofidentifying a target 14 and a pathway to the target 14 utilizingcomputed tomographic (“CT”) images, and once identified, further enablesthe use of a navigation or guidance system to position the EWC 12 of acatheter guide assembly 40, and medical instrument positionedtherethrough, relative to the target 14. In addition, the followingenables accurate live image confirmation of the location of the EWC 12prior, during, and after treatment.

CT image data facilitates the identification of a target 14, planning ofa pathway to an identified target 14, as well as providing the abilityto navigate through the body to the target 14 via a user interface. Thisincludes a preoperative component and an operative component (i.e.,pathway planning and pathway navigation) as will be described in furtherdetail below. Live fluoroscopic visualization of the placement of theEWC 12 and/or medical instruments positioned therethrough, relative tothe target 14 is enabled, thus enabling the clinician to actually seethe proper placement of the device relative to the target 14 in realtime using a combination of live fluoroscopic data and the CT image data(or selected portions thereof). Once placement of the medicalinstrument/EWC 12 is confirmed within the target 14, a surgicaltreatment or diagnostic sampling may be performed. For example,microwave energy can be transmitted to an ablation device positionedthrough EWC 12 to treat tissue located at the target 14.

Following treatment of tissue located at the target 14, the livefluoroscopic imaging may be utilized to confirm, for example, that asuitable ablation zone has been formed around the tissue and whetheradditional application of energy is necessary. These steps of treatingand imaging may be repeated iteratively until a determination is madethat the tissue located at the target 14 has been successfully treated.Moreover, the methodology described above using the imaging modalitiesto confirm the extent of treatment and determine whether additionalapplication of energy is necessary can be combined with the radiometryand temperature sensing techniques to both confirm what is depicted bythe imaging modality and to assist in determining treatment cessationpoints.

Turning now to FIGS. 4-7 , methods for performing enhanced navigationusing system 100 will now be described with particular detail. Althoughthe methods illustrated and described herein are illustrated anddescribed as being in a particular order and requiring particular steps,any of the methods may include some or all of the steps and may beimplemented in any order not specifically described.

With particular reference to FIG. 4 , a method for performing enhancednavigation is illustrated and will be described as method 400. Method400 begins with the pathway planning step 401. In embodiments, thepathway planning step 401 includes acquiring a first set of CT imagesfor generation of a first CT data set. However, the acquisition of theCT images and/or the generating of the CT data set may be completedprior to the pathway planning step 401 in which the pre-acquired CT dataset is uploaded into system 100. In embodiments, the pathway planningstep 401 includes three general steps. The first step involves usingsoftware for generating and viewing a three-dimensional model of thebronchial airway tree (“BT”) and viewing the CT data to identify targets(i.e., target 14). The second step involves using the software forselection of a pathway on the BT to the identified target 14, eitherautomatically, semi-automatically, or manually, if desired. Optionally,the pathway may be automatically segmented into a set of waypoints alongthe path that can be visualized on a display. In embodiments, a thirdstep may include confirmation of the plan using a fly-through view, andthen exporting the pathway plan for use in a navigation system. It is tobe understood that the airways are being used herein as an example of abranched luminal network. Hence, the term “BT” is being used in ageneral sense to represent any such luminal network (e.g., thecirculatory system, or the gastro-intestinal tract, etc.). Furtherdetails regarding the planning step are described in U.S. patentapplication Ser. No. 13/838,805, filed Mar. 15, 2013, the entirecontents of which are incorporated by reference herein.

Method 400 then proceeds to a first navigation step 403. In step 403,using the plan developed in step 401, an EWC 12 is navigated to a target14. Specifically, with reference back to FIGS. 1-3 , the plan developedin step 401 is imported into computing device 125, or generated bycomputing device 125, and the plan is registered with the patient's“P's” location enabling a clinician to follow the plan within thepatient's “P's” BT with EWC 12 and LG 32. A clinician follows the planby advancing the bronchoscope 30, and once the bronchoscope 30 iswedged, advancing the EWC 12 of the catheter guide assembly 40 throughthe working channel of the bronchoscope 30 to the target 14. Thelocation of the distal end of the EWC 12, where the LG 32 is located, ismonitored by the tracking system 50 as it is advanced through the BT.Further details regarding the navigation are described in U.S. Pat. No.7,233,820, the entire contents of which are hereby incorporated byreference in its entirety.

After navigating the EWC 12 proximate the target 14 (via the userinterface), in 404 the EWC 12 is used in conjunction with markerplacement tools and biopsy tools to place markers 20 in tissue locatedaround the target 14 and, optionally, for the retrieval of biopsysamples of the tissue proximate target 14. As understood by those ofskill in the art, and as described above, the target 14 is a computergenerated representation, created during the planning phase, of thetissue of interest identified by review of the CT image data. Thus,markers are placed in, and biopsy samples may be taken from, the tissueof the patient “P” at the location the navigation system identifies ascorresponding to the location of the target 14 in the pathway plan.

After the markers 20 are placed, the medical instrument used to placethe markers 20, along with the EWC 12, is removed from the patient's“P's” BT and the method proceeds to step 405 where a second set of CTimages is acquired for generating a second CT data set. The second CTdata set acquired in step 405 includes CT images of the patient “P”including the markers 20 placed in step 404. This may be performedimmediately or following cytopathologic examination of the biopsysamples.

Following acquisition of the second CT image set, analysis of any biopsysamples taken, and confirming that either further biopsy or treatment isnecessary, a new pathway plan is developed by the clinician and a secondnavigation step 407 is performed including navigating to the target 14using a pathway plan generated using the second CT data. This secondpathway plan may selectively include data from the navigation plangenerated in step 401 using the first CT data set. In step 407, the EWC12 is navigated to the target 14 in a similar manner as the firstnavigation step 403 and therefore will not be described in furtherdetail.

Subsequent to navigating the EWC 12 to the target 14 in step 407, method400 proceeds to step 409 to perform enhanced medical imaging and deviceplacement. Specifically, after the EWC 12 is navigated to the target 14in step 407, the LG 32 may again be removed from the EWC 12 and amedical instrument may be positioned proximate the target 14 via the EWC12. Fluoroscopic imaging is undertaken and a composite fluoroscopicimage 10 (FIG. 1 ) including data from the pathway plan data isdisplayed to the clinician. Step 409 enables a clinician to verify theposition of the medical instrument relative to the target 14 and makeadjustments to the position of the surgical device relative to thetarget 14 before performing a surgical procedure (i.e., retrieval ofsample tissue, ablation of tissue, placement of additional markers).Details with respect to enhanced medical device placement of step 409will be described in further detail below with respect to method 500 inFIG. 5 . Subsequent to performing the enhanced medical imaging deviceplacement in step 409, method 400 proceeds to step 411 where the medicalinstrument, properly positioned relative to the target 14 is used forits intended purposes (i.e., a microwave ablation device is activated totreat tissue, a biopsy tool retrieves a sample of tissue, a markerplacement tool places the marker(s)).

Turning now to FIG. 5 and with reference to FIGS. 1-3 , a method forperforming enhanced navigation will be described in particular detailand will be referred to as method 500. Method 500 begins at step 501after the EWC 12 is navigated to the target 14 following the secondnavigating step 407 of method 400 (FIG. 4 ). Method 500 may be used toconfirm placement of the EWC 12, or any medical instrument positionedthrough the EWC 12, relative to the target 14 to verify and adjust itsposition relative to the target 14 prior to performing a surgicalprocedure (i.e., retrieving a sample of the target tissue, ablating thetarget tissue).

In step 501, a real-time fluoroscopic image of the patient “P” iscaptured. FIG. 6 illustrates an example of a real-time fluoroscopicimage 601 captured in step 501. The real-time fluoroscopic image 601 iscaptured using the imaging device 110 (FIG. 3 ). As seen in FIG. 6 , themarkers 20 placed in the proximity of the target 14 (step 404 of method400) and the EWC 12 previously navigated to the target 14 in the pathwayplan (step 407 of method 400) are visible in the captured fluoroscopicimage 601. In embodiments, step 501 includes capturing a series offluoroscopic images of the target region and/or a live fluoroscopicvideo stream.

In step 503 the fluoroscopic image 601 captured in step 501 isregistered with the second CT data set acquired in step 405 of method400. In embodiments, the registration of the fluoroscopic image 601 andthe second CT data set is based on a comparison of the position andorientation of the markers 20 within the fluoroscopic image 601 and theposition and orientation of the markers 20 within the second CT data set(not shown). Specifically, computing device 125 detects markers 20 inthe CT images of the second CT data set using methods such as intensitythresholding or via clinician manual identification. Possible falseindicators such as from calcification or other metal objects visible inthe CT images may be detected and disregarded. In embodiments, thesecond CT data set may be displayed for a clinician to identify themarkers 20 on a graphical user interface. Additionally, in step 503, thecomputing device 125 detects the markers 20 depicted in the fluoroscopicimage(s) 601 acquired in step 501. For marker 20 detection in thefluoroscopic image(s) 601, computing device 125 may employ techniquessuch as contrast detection, intensity detection, shape detection,minimum axis detection, and/or any combinations thereof. Additionally,computing device 125 may also detect the marker center and marker endpoints for each marker 20 detected. After detecting the markers 20 inthe fluoroscopic image 601 acquired in step 501 and the CT data setstored in computing device 125, computing device 125 then registers thefluoroscopic image 601 with the CT data set by comparing one or more ofthe position, length, angle, orientation, and distance between each ofthe markers 20 or between all of the markers 20 with the CT data set.

In step 507, the fluoroscopic image(s) 601 and/or video captured in step501 is displayed on the display of computing device 125.

In step 509, computing device 125 analyzes the position and/ororientation of the markers 20 depicted in the fluoroscopic image 601 andperforms a mathematical calculation to identify a 2D slice of the 3Dmodel generated from the second CT data set such that one or more of theposition, length, angle, orientation, and distance between each of themarkers 20 or between all of the markers 20 in the identified 2D slicecorrespond with the same factors in the fluoroscopic image. This may beperformed in conjunction with position and/or orientation data receivedfrom the imaging device 110. Once the 2D image from the CT data setcorresponding to the fluoroscopic image is ascertained, the clinicianmay selectively identify what portions of the data included on the 2Dimage to incorporate into the displayed fluoroscopic image 601.Alternatively, data from the fluoroscopic image 601 may be incorporatedinto the 2D image from the CT data set. As an example, the target 14which was identified in the CT data set during the planning phase may beavailable for selection. In addition, the pathway 16 and luminal network18, as well as other data from the CT data set may be available forselection. As a result, a clinician may select an object that isviewable in a CT image of the CT data set that is not viewable in thefluoroscopic image 601 (i.e., a portion of soft tissue), such that theselection may be combined with the fluoroscopic image 601 to create acombined image 10 (FIG. 1 ).

In addition to permitting selection, the computing device 125 may alsooutput an indicator of resolution of the markers 20 from thefluoroscopic image in the CT data set. For example, in FIG. 1 eachmarker 20 is circumscribed by a line indicating that it has beenpositively identified. If markers 20 are not resolved in the CT dataset, this may be an indicator that the 2D image and the fluoroscopicimage 601 are not actually registered to one another, and provides anindicator to the clinician that they may wish to perform anotherfluoroscopic imaging before proceeding.

In step 511, with reference with FIG. 1 , the combined or compositeimage 10 is displayed on the display of computing device 125 and/oranother device. The combined image 10 displayed in step 511 includes theportion selected in step 509 (e.g., the target 14) and the fluoroscopicimage(s) 601 (FIG. 6 ) or video displayed in step 507. The combinedimage 10 may be a fused image, an overlay of images, or any otherdisplay of multiple images and/or video known in the art. For example,as illustrated in FIG. 1 , where a user selects the target 14 in animage of the CT data in step 509 (or when the target 14 is automaticallyselected in step 509), in step 511 the combined image 10 includes thefluoroscopic image 601 (FIG. 6 ) (including visibility of the markers 20and EWC 12 as well as any medical instrument, placed therein) and theselection of the image of the CT data set (the target 14). Using theregistration between the fluoroscopic image(s) 601 and/or video and theCT data set in step 503, the system 100 determines where the selectedportion (e.g., target 14) is to be positioned (i.e., overlay, fused,etc.) within the fluoroscopic image 601 and/or video to create thecombined image 10.

In step 513, the position of the EWC 12, or the medical instrumentpositioned within the EWC 12, is adjusted relative to the target 14 anddisplayed using the combined image 10 generated in step 511. Furtherdetails regarding the adjustment in step 511 will be described infurther detail below with reference to FIG. 7 .

Turning now to FIG. 7 , a method for adjusting the position/placement ofthe EWC 12, or the medical instrument positioned therein, will now bedescribed and referred to as method 700. After navigating the EWC 12 tothe target 14, in order to ensure that the medical instrument positionedwithin the EWC 12 of the catheter guide assembly 40 is properlypositioned relative to the target 14, using method 700 a clinician canensure that the medical instrument is properly positioned or otherwiseadjust the position of the medical instrument relative to the target 14until it is properly positioned. Method 700 begins at step 701 where amedical instrument is positioned relative to a target 14 via the EWC 12.

In step 703, using imaging device 110, a fluoroscopic image/video iscaptured from a first angle. The fluoroscopic image/video captured instep 703 is transmitted to computing device 125 for display on agraphical user interface and for the generation of a combined image 10(FIG. 1 ). Viewing the combined image 10, which displays both the target14 and the medical instrument in real-time relative to the target 14, aclinician may determine whether the position of the medical instrumentrelative to the target 14 is correct (step 705). If the position of themedical instrument relative to the target 14 is correct (yes in step705) then method 700 proceeds to step 706. Alternatively, if theposition of the medical instrument is not correct (no in step 705), thenmethod 700 proceeds to step 706.

In step 706, a clinician adjusts the position of the medical instrumentby manipulating the catheter guide assembly 40 and therewith the EWC 12and any medical instrument located therein. If the imaging device 110 iscapturing a live video, then the adjustment of the medicalinstrument/EWC 12 in step 706 is viewed in real time on the display ofcomputing device 125 or any other suitable devices. However, if theimaging device 110 is only capturing an image, then a method 700 revertsback to step 703 where a new fluoroscopic image is captured displayingthe new/adjusted position of the medical instrument/EWC 12. This processis repeated until the position of the medical instrument/EWC 12 iscorrect (yes in step 705). Once the position of the EWC 12 is correct(yes in step 705), then method 700 proceeds to step 707.

In step 707, a second fluoroscopic image/video is captured from a secondangle relative to the patient. That is, the imaging device 110 is movedto a new location such that a second fluoroscopic image/video may becaptured from a different viewing angle. The fluoroscopic image/videocaptured in step 707 is transmitted to computing device 125 for displayon a graphical user interface and for the generation of the combinedimage 10 (FIG. 1 ). Viewing the combined image 10, which displays boththe target 14 and the medical instrument in real-time relative to thetarget 14, a clinician may determine whether the three-dimensionalposition of the medical instrument relative to the target 14 is correct(step 709). If the three-dimensional position the medical instrumentrelative to the target 14 is correct (yes in step 709), then method 700proceeds to step 711. Alternatively, if the three-dimensional positionof the medical instrument is not correct (no in step 709), then method700 proceeds to step 710.

In step 710, the clinician adjusts the three-dimensional position of themedical instrument relative to the target 14 by pushing/pulling thecatheter guide assembly 40 and therewith the EWC 12 and any medicalinstrument located therein relative to the target 14. Because of theadjustment of the three-dimensional position of the medicalinstrument/EWC 12, a clinician may wish to revert back to step 703 toview the position of the medical instrument/EWC 12 relative to thetarget 14 again from the first angle.

Once the three-dimensional position of the medical instrument/EWC 12relative to the target 14 is correct (yes in step 709), method 700proceeds to step 711 where the treatment is performed. As describedabove, depending on the intended treatment to be performed, thetreatment may include retrieving samples of tissue for biopsy ortesting, ablating tissue located at the target 14, placing markers 20 orany other suitable surgical procedure.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. For example, one or modifications may be made in the way ofdevice delivery and placement; device cooling and antenna buffering; andsensor feedback.

As can be appreciated a medical instrument such as a biopsy tool or anenergy device, such as a microwave ablation catheter, that ispositionable through one or more branched luminal networks of a patientto treat tissue may prove useful in the surgical arena and the presentdisclosure is directed to such apparatus, systems, and methods. Accessto luminal networks may be percutaneous or through natural orifice. Inthe case of natural orifice, an endobronchial approach may beparticularly useful in the treatment of lung disease. Targets,navigation, access and treatment may be planned pre-procedurally using acombination of imaging and/or planning software. In accordance withthese aspects of the present disclosure, the planning software may offercustom guidance using pre-procedure images. Navigation of the luminalnetwork may be accomplished using image-guidance. These image-guidancesystems may be separate or integrated with the energy device or aseparate access tool and may include MRI, CT, fluoroscopy, ultrasound,electrical impedance tomography, optical, and/or device trackingsystems. Methodologies for locating the access tool include EM, IR,echolocation, optical, and others. Tracking systems may be integrated toan imaging device, where tracking is done in virtual space or fused withpreoperative or live images. In some cases the treatment target may bedirectly accessed from within the lumen, such as for the treatment ofthe endobronchial wall for COPD, Asthma, lung cancer, etc. In othercases, the energy device and/or an additional access tool may berequired to pierce the lumen and extend into other tissues to reach thetarget, such as for the treatment of disease within the parenchyma.Final localization and confirmation of energy device placement may beperformed with imaging and/or navigational guidance using the modalitiesdescribed below. The energy device has the ability to deliver an energyfield for treatment (including but not limited to electromagneticfields).

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

What is claimed is:
 1. A method for enhanced surgical navigation,comprising: generating a first navigation path based on a first data setof computed tomography (CT) images of a branched luminal network, thefirst navigation path defining a route through the branched luminalnetwork to a target; displaying the route of the first navigation pathfor navigation to the target; receiving a second data set of CT imagesof the branched luminal network, the second data set of CT imagesincluding a marker proximate the target; generating a three-dimensionalmodel of the branched luminal network based on the second data set of CTimages; generating a second navigation path to the target based on thethree-dimensional model, the second navigation path defining a secondroute through the branched luminal network to the target; displaying thesecond route to the target; registering fluoroscopic data of tissueproximate the marker to at least one of the first data set of CT imagesor the second data set of CT images; and creating a compositefluoroscopic image including: the fluoroscopic data; an object derivedfrom the second data set of CT images; and a representation of thebranched luminal network derived from the second data set of CT images.2. The method according to claim 1, further comprising displaying thecomposite fluoroscopic image as a medical instrument is navigated totissue proximate the target.
 3. The method according to claim 1, whereindisplaying the route of the first navigation path for a first navigationto the target by following the route includes displaying the route ofthe first navigation path for a first navigation to the target byfollowing the route and for placement of a plurality of markers intissue proximate the target.
 4. The method according to claim 1, whereinthe composite fluoroscopic image further includes a representation ofthe second route through the branched luminal network from the seconddata set of CT images.
 5. The method according to claim 1, furthercomprising: displaying a representation of the second data set of CTimages; and displaying the fluoroscopic data.
 6. The method according toclaim 1, further comprising: receiving a selection of at least a portionof the second data set of CT images or the fluoroscopic data; andcombining the selection with at least one of the second data set of CTimages or the fluoroscopic data into the composite fluoroscopic image.7. The method according to claim 1, wherein the composite fluoroscopicimage includes at least one of a fused, superimposed, or overlaid imageof at least a portion of the second data set of CT images with thefluoroscopic data.
 8. The method according to claim 1, wherein thefluoroscopic data includes image data of a medical instrument positionedrelative to tissue proximate the target and the method furthercomprises: determining whether the medical instrument is correctlypositioned relative to the target based on an analysis of the compositefluoroscopic image.
 9. The method according to claim 8, furthercomprising: acquiring second fluoroscopic data of tissue proximate themarker from an imaging device; and determining whether athree-dimensional position of the medical instrument relative to thetarget is correct based on an analysis of the second fluoroscopic data.10. The method according to claim 1, wherein the fluoroscopic data isreal-time fluoroscopic video of tissue proximate the marker.
 11. Themethod according to claim 1, wherein the fluoroscopic data is at leastone a fluoroscopic image of tissue proximate the marker.
 12. The methodaccording to claim 1, wherein registering fluoroscopic data of tissueproximate the marker to the second data set of CT images includesregistering the fluoroscopic data to the second data set of CT imagesbased on a position and orientation of the marker.
 13. The methodaccording to claim 1, further comprising: identifying a slice of thesecond data set of CT images having a marker position and orientationcorresponding to a marker position and orientation within thefluoroscopic data; and registering the fluoroscopic data to the seconddata set of CT images based on the slice.
 14. A method for enhancedsurgical navigation comprising: receiving a data set of CT images of abranched luminal network, the data set of CT images including a markerproximate a target; generating a three-dimensional model of the branchedluminal network based on the data set of CT images; generating anavigation path through the branched luminal network based on thethree-dimensional model, the navigation path defining a route throughthe branched luminal network to the target; displaying the route througha representation of the branched luminal network for navigation to thetarget; registering live fluoroscopic data of tissue proximate themarker to the data set of CT images; and creating a two-dimensional (2D)composite fluoroscopic image including: the live fluoroscopic data; a 2Drepresentation of an object derived from the data set of CT images; andthe representation of the branched luminal network.
 15. The methodaccording to claim 14, wherein registering the live fluoroscopic data oftissue proximate the marker to the data set of CT images includesregistering the live fluoroscopic data to the data set of CT imagesbased on a position and orientation of the marker.
 16. The methodaccording to claim 14, wherein the marker includes a plurality ofmarkers.
 17. The method according to claim 14, wherein the markerincludes a portion of a medical tool positioned proximate the target.18. The method according to claim 14, wherein registering the livefluoroscopic data of tissue proximate the marker to the data set of CTimages includes registering a series of live fluoroscopic images to thedata set of CT images.
 19. A method for enhanced surgical navigationcomprising: receiving a data set of CT images of a branched luminalnetwork; generating a three-dimensional model of the branched luminalnetwork from the data set of CT images; generating a navigation paththrough the branched luminal network based on the three-dimensionalmodel, the navigation path defining a route through the branched luminalnetwork to a target; displaying the route through a representation ofthe branched luminal network for navigation of a medical tool to thetarget; registering fluoroscopic data of tissue proximate the target tothe data set of CT images based on a position and orientation of themedical tool within the fluoroscopic data; and creating atwo-dimensional (2D) composite fluoroscopic image including: the livefluoroscopic data; a 2D representation of an object derived from thedata set of CT images; the representation of the branched luminalnetwork; the medical tool; and the route defined by the navigation path.20. The method according to claim 19, wherein registering the livefluoroscopic data of tissue proximate the target to the data set of CTimages includes registering a series of live fluoroscopic images to thedata set of CT images.